BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1925881 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06360
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 4, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS INDICATES A LOW TELEMETERED BATTERY VOLTAGE. ON (B)(4) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.10 V, WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.89 V. (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS INDICATES A LOW TELEMETERED BATTERY VOLTAGE. ON (B)(4) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.10 V, WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.89 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASUREMENT WAS LOW AND ELECTIVE REPLACEMENT INDICATOR WAS NOT SET. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASUREMENT WAS LOW AND ELECTIVE REPLACEMENT INDICATOR WAS NOT SET. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASUREMENT WAS LOW AND ELECTIVE REPLACEMENT INDICATOR WAS NOT SET. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) PREMATURELY, AS THE DEVICE TESTED OKAY IN (B)(6) 2011 AND THEN THREE MONTHS LATER, THE DEVICE WAS AT ERI. IT WAS ALSO NOTED THAT IT SEEMED THAT THE DEVICE WAS PART OF THE "BAD" GROUP. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD